Exposure-Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma

Exposure-Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma

Authors: Hamuro L, Hu Z, Passarell JA, Barcomb H, Zhang J, Goldstein S, Bello A, Roy A, Zhu L
Publication: Clin Cancer Res
Keywords: advanced renal cell carcinoma, cabozantinib, CheckMate 9ER trial, exposure-response, nivolumab
Division: Clinical Pharmacology and Pharmacometrics (CPP)

A benefit:risk assessment for a less-frequent nivolumab 480 mg Q4W + cabozantinib 40 mg QD dosing regimen was predicted using modeling and simulation of clinical trial data from nivolumab monotherapy studies and

A supramolecular thermosensitive gel of ketoconazole for ocular applications: In silico, in vitro, and ex vivo studies

A supramolecular thermosensitive gel of ketoconazole for ocular applications: In silico, in vitro, and ex vivo studies

Authors: Chaudhari P, Naik R, Sruthi Mallela L, Roy S, Birangal S, Ghate V, Balladka Kunhanna S, Lewis SA
Publication: Int J Pharm
Keywords: biopharmaceutics, eye tissue, gastroplus, mechanistic absorption model, ocular, pbbm, PBPK model, PBPK modeling
Software: GastroPlus®

The incidence of corneal fungal infections continues to be a growing concern worldwide.

Using PBPK M&S to support the development of an IR tablet formulation & setting more relevant dissolution test specifications

Using PBPK M&S to support the development of an IR tablet formulation & setting more relevant dissolution test specifications

Authors: Duque MD
Keywords: amiodarone, dissolution, gastroplus, IR tablet formulation, pbbm, pbpk modeling and simulation, University+, University+ Program
Software: GastroPlus®
Division: PBPK

Development of formulation and setting dissolution test specifications for IR tablets based on PBPK modeling & simulation – amiodarone as a case example

Predicting the Drug–Drug Interaction Mediated by CYP3A4 Inhibition: Method Development and Performance Evaluation

Predicting the Drug–Drug Interaction Mediated by CYP3A4 Inhibition: Method Development and Performance Evaluation

Authors: Ren HC, Sai Y, Chen T, Zhang C, Tang L, Yang CG
Publication: AAPS J
Keywords: ctyochrome p450, CYP Enzymes, ddI, Drug-drug interactions, gastroplus, metabolic inhibition, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

The prediction of drug–drug interactions (DDIs) plays critical roles for the estimation of DDI risk caused by inhibition of CYP3A4.

Population pharmacokinetic modeling and stochastic simulations to support pediatric dose selection of pimavanserin

Population pharmacokinetic modeling and stochastic simulations to support pediatric dose selection of pimavanserin

Authors: Darwish M, Bugarski-Kirola D, Jaworowicz DJ, Owen JS, AlQaraghuli F
Conference: American College of Neuropsychopharmacology
Keywords: 5HT2A receptor, 5HT2C receptor, Dementia-related Psychosis, Depressive Disorder, onin receptor-modulating agent, pharmacokinetics, pimavanserin, schizophrenia
Division: Clinical Pharmacology and Pharmacometrics (CPP), PBPK

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3D Printed Buccal Films for Prolonged-Release of Propranolol Hydrochloride: Development, Characterization and Bioavailability Prediction

3D Printed Buccal Films for Prolonged-Release of Propranolol Hydrochloride: Development, Characterization and Bioavailability Prediction

Authors: Jovanović M, Petrovic M, Cvijić S, Tomić N, Stojanović D, Ibric S, Uskoković P
Publication: Pharmaceutics
Keywords: formulation design, formulation design: gastroplus, gastroplus, intraoral, mechanistic absorption model, occat, oral cavity, pbbm, PBPK modeling, physiologically based biopharmaceutics
Software: GastroPlus®

Gelatin-polyvinylpyrrolidone (PVP) and gelatin-poly(vinyl alcohol) (PVA) mucoadhesive buccal films loaded with propranolol hydrochloride (PRH) were prepared by semi-solid extrusion 3D printing.

Current Practices, Gap Analysis and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective

Current Practices, Gap Analysis and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective

Authors: Hariparsad N, Ramsden D, Taskar K, Badée J, Venkatakrishnan K, Reddy MB, Cabalu T, Mukherjee D, Rehmel J, Bolleddula J, Emami Riedmaier A, Prakash C, Chanteux H, Mao J, Umehara K, Shah K, De Zwart L, Dowty M, Kotsuma M, Li M, Pilla Reddy V, McGinnity DF, Parrott N
Publication: Pharmacol Ther
Keywords: CYP Enzymes, ddI, Drug-drug interactions, gastroplus, metabolic induction, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

The International Consortium for Innovation and Quality (IQ) Physiologically Based Pharmacokinetic modeling (PBPK) Induction Working Group (IWG) conducted a survey across participating companies around general strategies for PBPK modeling of...

Simulations Plus Extends its Distributor Agreement in Japan with Northern Science Consulting for Monolix™

Simulations Plus Extends its Distributor Agreement in Japan with Northern Science Consulting for Monolix™

Keywords: consulting, Goh Murakami, Japan, Japanese pharmaceutical industry, MonolixSuite, MonolixSuite Playlist, Northern Science Consulting
Software: ADMET Predictor®, GastroPlus®, Monolix®
Division: Clinical Pharmacology and Pharmacometrics (CPP), PBPK

Complementing the existing distributorship with ADMET Predictor® and GastroPlus® software

Stimuli to the Revision Process: The Case for Apex Vessels Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts

Stimuli to the Revision Process: The Case for Apex Vessels Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts

Authors: Mann J, Cohen M, Abend A, Coutant C, Ashworth L, Shaw R
Publication: Dissolut Technol
Keywords: biopharmaceutics, dissolution, gastroplus, in vitro, mechanistic absorption model, pbbm, PBPK modeling
Software: GastroPlus®

Apex vessels (previously known as PEAK vessels) are an important element of the dissoluton scientst's toolbox and are frequently used in pharmaceutcal drug product development setngs

Validation of non-compartmental analysis (NCA) and bioequivalence results of PKanalix with respect to Phoenix WinNonLin

Validation of non-compartmental analysis (NCA) and bioequivalence results of PKanalix with respect to Phoenix WinNonLin

Authors: Pasquiers B, Gualano V, Twarogowska M, Ayral G
Keywords: bioequivalence, compartmental analysis (CA), drug-drug interactions (DDIs), Food effects, MonolixSuite Playlist, noncompartmental analysis (NCA), pharmacokinetics, pkanalix feature
Software: Monolix®, PKanalix®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Non-compartmental analysis (NCA) is used at all stages of drug development and is a key method to understand the pharmacokinetic properties of a compound.

Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia

Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia

Authors: Junnarkar G, Allphin C, Profant J, Steininger TL, Chen C, Zomorodi K, Skowronski R, Black J
Publication: Expert Opin Drug Discov
Keywords: formulation design, gastroplus, mechanistic absorption model, pbbm, PBPK modeling, physiologically based biopharmaceutics, salt selection, virtual populations
Software: GastroPlus®

Sodium oxybate (SXB) is a standard of care for cataplexy, excessive daytime sleepiness, and disrupted nighttime sleep in narcolepsy.

PBPK Modeling and Simulation and Therapeutic Drug Monitoring: Possible Ways for Antibiotic Dose Adjustment

PBPK Modeling and Simulation and Therapeutic Drug Monitoring: Possible Ways for Antibiotic Dose Adjustment

Authors: Ferreira A, Lapa R, Vale N
Publication: Processes
Keywords: biopharmaceutics, dose selection, gastroplus, mechanistic absorption model, pbbm, PBPK modeling, pediatrics, virtual populations
Software: GastroPlus®
Division: PBPK

Pharmacokinetics (PK) is a branch of pharmacology present and of vital importance for the research and development (R&D) of new drugs, post-market monitoring, and continued optimizations in clinical contexts.